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Study of MK-3475 (Pembrolizumab) in Patients With Microsatellite Unstable (MSI) Tumors (Cohort D) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of MK-3475 (Pembrolizumab) in Patients With Microsatellite Unstable (MSI) Tumors (Cohort D)

Phase 2 Study of MK-3475 (Pembrolizumab) in Patients With Microsatellite Unstable (MSI) Tumors

NCT04098068•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

This study will be looking at whether MK-3475 (pembrolizumab) is effective (anti-tumor activity) and safe in patients with MSI (Microsatellite Unstable) negative cancer with a mutator phenotype.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with microsatellite stable tumor and a tumor mutation burden (TMB) level measured at \> 20 mutations per megabase pairs (MB)
•Have measurable disease
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
•Adequate organ function as defined by study-specified laboratory tests
•Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
•Signed informed consent form
•Willing and able to comply with study procedures
•Agree to have a biopsy of their cancer
•Patients with colon cancer must have received at least two prior cancer therapy regimens.
•Patients with other cancer types must have received at least one prior cancer therapy
+1 more criteria

Exclusion Criteria

•Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements.
•Patients who have had chemotherapy or biological cancer therapy within 2 weeks prior to the first dose of study drug
•Patients who have had radiation within 2 weeks prior to the first dose of study drug
•Patients who have undergone major surgery within 4 weeks of dosing of investigational agent
•Patients who have received another investigational product or investigational device within 4 weeks prior to receiving study drug
•Patients who have received any of the following concomitant therapy: Interleukin-2 (IL-2), interferon, or other non-study immunotherapy regimens, immunosuppressive agents, other investigational therapies or chronic use of systemic corticosteroids within one week prior to first dose of study drug
•Patients who have received a live vaccine within 4 weeks prior to or after any dose of MK-3475 (exception: inactivated flu vaccines)
•Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration
•Patient who have had prior treatment with anti-PD-1 (anti-programmed cell death protein 1), anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies
•Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus (SLE) autoimmune vasculitis, central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin.
+12 more criteria

Locations (3)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Key Dates

Start Date

January 25, 2018

Primary Completion Date

May 15, 2022

Completion Date

February 5, 2025

Last Updated

March 30, 2025

Enrollment

ACTUAL participants

Conditions

High Tumor Mutation BurdenHigh TMB (Tumor Mutation Burden)MSS (Microsatellite Stable)

Interventions

MK-3475

DRUG